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The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham device during these two months while not knowing which device they have been provided. At the end of the two months, all patients will be asked to continue in the study for another 2 months to self administer with the active AlphaCore device. Subjects will complete diaries at home on their breathing and quality of life and will return to the clinic monthly for assessment by the investigator.
PERFORMANCE AND SAFETY VARIABLES:
The primary efficacy endpoint for this study is the total Chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) score change from baseline to the 8 week follow-up period comparing the two device groups.
Secondary efficacy endpoints will be the mean difference from baseline to the 8 week follow-up for the following assessments: Medical Research Council (MRC) dyspnoea scale, 6 minutes walking test and Forced Expiratory Volume in one second (FEV1)
Safety Variables:
Each subject will be assessed throughout the study for Adverse Events and at the last visit (4 months) subjects will undergo another physical examination including vital signs and blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active AlphaCore device | Active Comparator | AlphaCore active stimulation treatment |
|
| Sham AlphaCore device | Sham Comparator | AlphaCore sham device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaCore device | Device | Each study group will go under the same treatment regimen and assessments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups | Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Borg Dyspnoea Scores | Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8 | Baseline vs 8 weeks |
| Change 6 Minutes Walking Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias John, MD | Praxis für Pneumologie am Asklepios Klinikum Uckermark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis fur Pneumologie am Asklepios Klinikum Uckermark | Schwedt | Oder | D-16303 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active AlphaCore Device | AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments. |
| FG001 | Sham AlphaCore Device | AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active AlphaCore Device | AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments. |
| BG001 | Sham AlphaCore Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups | Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline. | One patient in the Active AlphaCore device Group missing data at 8 weeks. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
16 weeks
The first 8 weeks randomized controlled, the last 8 weeks open label
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active AlphaCore Device | AlphaCore active stimulation treatment AlphaCore device: Each study group will go under the same treatment regimen and assessments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute COPD exacebartion | Respiratory, thoracic and mediastinal disorders | COPD exacerbation | Non-systematic Assessment | Hospitalized/Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Respiratory, thoracic and mediastinal disorders | Common cold | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annelie Andersson | electroCore LLC | +46 721 803076 | annelie.andersson@electrocorellc.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups |
| Baseline vs 8 weeks |
| Change in Forced Expiratory Volume (FEV1) | Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation. Change from baseline to week 8 between treatment groups | Baseline vs 8 weeks |
| Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) | The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label. Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index | Baseline vs 8 weeks |
| Number of Subjects With Adverse Events (AE) | All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.
| Throughout the course of the study (baseline to the 4 month follow-up visit) |
| Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) | Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state | Baseline vs 8 weeks |
AlphaCore sham device
AlphaCore device: Each study group will go under the same treatment regimen and assessments.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham AlphaCore Device | AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments. |
|
|
| Secondary | Change in Borg Dyspnoea Scores | Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8 | One subject in the Active AlphaCore device Group missing data at 8 weeks. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline vs 8 weeks |
|
|
|
| Secondary | Change 6 Minutes Walking Test | Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups | One patient in the Active AlphaCore group is missing data at week 8 | Posted | Mean | Standard Deviation | Meter | Baseline vs 8 weeks |
|
|
|
| Secondary | Change in Forced Expiratory Volume (FEV1) | Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation. Change from baseline to week 8 between treatment groups | One subject in the Active AlphaCore group missing data at week 8 | Posted | Mean | Standard Deviation | Percentage of predicted value | Baseline vs 8 weeks |
|
|
|
| Secondary | Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) | The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label. Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index | One patient in the Active AlphaCore group is missing data at 8 weeks. | Posted | Number | participants | Baseline vs 8 weeks |
|
|
|
| Secondary | Number of Subjects With Adverse Events (AE) | All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.
| All subjects reporting any Adverse Event | Posted | Number | participants | Throughout the course of the study (baseline to the 4 month follow-up visit) |
|
|
|
| Secondary | Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) | Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state | One patient in the Active AlphaCore group missing data at 8 weeks. | Posted | Mean | Standard Deviation | units on a scale | Baseline vs 8 weeks |
|
|
|
| 3 |
| 26 |
| 4 |
| 26 |
| EG001 | Sham AlphaCore Device | AlphaCore sham device AlphaCore device: Each study group will go under the same treatment regimen and assessments. | 1 | 28 | 3 | 28 |
|
| Cartoid stenosis left | Vascular disorders | Cartoid stenosis | Non-systematic Assessment | Hospitalized/Not related |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Pulmonary embolism | Non-systematic Assessment | Hospitalized/Not related |
|
| Bronchopneumonia both sides | Respiratory, thoracic and mediastinal disorders | Bronchopneumonia | Non-systematic Assessment | Hospitalized/Not related |
|
| Infection of the respiratory tract | Respiratory, thoracic and mediastinal disorders | Respiratory infectio | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Self Care-no problem baseline |
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| Self Care-no problem week 8 |
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| Daily Activiies-no problem baseline |
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| Daily Activies- no problem week 8 |
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| Pain-no problem baseline |
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| Pain-no problem week 8 |
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| Anxiety-no problem baseline |
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| Anxiety-no problem week 8 |
|